Cleared Special

IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)

K013134 · Diagnostic Products Corp. · Immunology
Oct 2001
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K013134 is an FDA 510(k) clearance for the IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS), a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 15, 2001, 26 days after receiving the submission on September 19, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K013134 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2001
Decision Date October 15, 2001
Days to Decision 26 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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